Sruthi Vunnamatla
Sr Drug Safety Physician @Parexel
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WORK HISTORY
Sr Drug Safety Physician @Parexel
IN
EDUCATION
Dali medical university
Bachelor of Medicine, Bachelor of Surgery - MBBS
ABOUT SRUTHI VUNNAMATLA
I\'m Dr.Sruthi MBBS, Successfully completed fellowship in Pediatrics, gained extensive clinical and academic experience.qualified, licensed,with more than 4 years of clinical experience as emergency medical officer, currently working as a senior drug safety physician / Medical reviewer in the Pharmacovigilance sector with 4 years of hands on experience.* Skilled in Medical Assessment of Individual Case Safety Reports (ICSRs) literature review and clinical trial cases.* Skilled in Aggregate Reporting Preparing Periodic Benefit-Risk Evaluation Reports (PBRERs), Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs), Development Safety Update Reports (DSURs). Strongunderstanding of ICH E2E guidelines, GVP modules, and global regulatory requirements.* Expert at solving queries related to MedDRA coding and Event selection.* Good knowledge of ICH guidelines, VP and regulations relating to Safety and PharmacovigilanceWHO MedDRA, SUSAR, IME Criteria, Labelling and Causality MedDRA, ICSR form, Good Clinical practice (GCP),assessment, ARGUS & ARISg data Base.
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